11 results
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…
Question: Is it an added value for the patient if there will be a default capsaicin provocation test to diagnose chronic cough?It will be investigated or with the aid of the capsaicin provocation test the diagnosis sensory hyperreactivity (SHR) can…
-To investigate the feasibility, applicability, safety, tolerability, and reproducibility of addition of the capsaicin-heat model and the thermal grill to the existing nociceptive pain test battery in healthy subjects.-To investigate the feasibility…
The purpose of the study is to assess the safety and efficacy of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.
Primary:Part I:- to determine the effects of gabapentin and remifentanil on the evoked area of hyperalgesia, area of allodynia, pinprick hyperalgesia and background pain using a newly developed HCW sensitization modelPart II: - to determine…
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl.
Primary objectivePart A• Evaluating the effect and reproducibility of the capsaicin sensitization model on the predefined primary endpoints in both primary and secondary hyperalgesia areas for LS• Evaluating the effect and reproducibility of the…
* The primary objective of this study is to compare the proportion of warm antibody autoimmune hemolytic anemia (wAIHA) subjects whoachieve a durable hemoglobin response between the fostamatinib and placebo groups.* The secondary objectives of this…
Primary objective:To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in the 24-hr average pain intensity in subjects with PSNP.Secondary objective:• To demonstrate superiority of Qutenza over low…